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Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

NCT ID: NCT01438736

Last Updated: 2011-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.

Detailed Description

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Conditions

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Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Desogestrel, Etonogestrel

Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months

Group Type EXPERIMENTAL

Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)

Intervention Type DRUG

Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months

Etonogestrel

Arm 2: Women staring straight with Nexplanon implant for 6 months

Group Type EXPERIMENTAL

Etonogestrel 68 mg subdermal implant

Intervention Type DRUG

Etonogestrel 68 mg subdermal implant for 6 months

Interventions

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Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)

Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months

Intervention Type DRUG

Etonogestrel 68 mg subdermal implant

Etonogestrel 68 mg subdermal implant for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy women, 18-40 years of age
* regular menstrual cycle (period 23-35 days)

Exclusion Criteria

* -Immediate previous use of progestin only contraception within 2 months
* Known or suspected pregnancy
* Acute tromboembolic disorder
* Presence or history of hepatic disease, as long as the liver function values have not returned to normal
* Undiagnosed vaginal bleeding
* Known or suspected sex-steroid influenced malignancies (e.g. breast cancer)
* Hypersensitivity to the active substances or to any of the excipients of the medicines
* Pregnant or breast feeding within 6 weeks
* The use of other medicinal products that might interact with contraceptive steroids and affect the efficacy of contraceptives and/or might may lead to bleeding irregularities (especially medicines that induce the liver enzyme systems such as cytochrome P450). Examples of active substances are: phenytoin, phenobarbital, primidone, bosentan, carbamatzepine, rifampicin and medicinal products or herbal preparations containing ST.John's wort and to a lesser extend oxcarbazepine, topiramate, felbamate and griseofulvin.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

VL-Medi Oy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Apter, Docent

Role: PRINCIPAL_INVESTIGATOR

VL-Medi Oy

Locations

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VL Medi Oy

Helsinki, , Finland

Site Status

Countries

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Finland

Central Contacts

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Dan Apter, Docent

Role: CONTACT

[email protected]
+358405550842

Other Identifiers

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IIPS#39689

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EudraCT 2011-001492-39

Identifier Type: -

Identifier Source: org_study_id